EUCTR2018-000539-29-IT
Active, not recruiting
Phase 1
PeriOperative ISchemic Evaluation – 3 Trial (POISE-3). - POISE-3
ConditionsThe occurrence of life-threatening, major, and critical organ bleeding in patients who are undergoing noncardiac surgery.MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsUGUROL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The occurrence of life-threatening, major, and critical organ bleeding in patients who are undergoing noncardiac surgery.
- Sponsor
- Hamilton Health Sciences Corporation
- Enrollment
- 10000
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •o Undergoing noncardiac surgery;
- •o \>\= 45 years of age;
- •o Expected to require at least an overnight hospital admission after surgery
- •o Provide written informed consent to participate in the POISE\-3 Trial, AND
- •o Fulfill \>\=1 of the following:
- •NT\-proBNP \>\= 200 ng/L
- •History of coronary artery disease
- •History of peripheral arterial disease
- •History of stroke
- •Undergoing major vascular surgery
Exclusion Criteria
- •o Patients undergoing cardiac surgery
- •o Patients undergoing cranial neurosurgery
- •o Planned use of systemic TXA during surgery
- •o Hypersensitivity or known allergy to TXA
- •o Creatinine clearance \<30 mL/min (Cockcroft\-Gault equation) or on chronic dialysis
- •o Patients undergoing surgery for pheochromocytoma or history of untreated pheochromocytoma,
- •o History of seizure disorder
- •o Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous
- •thromboembolism (\<3 month)
- •o Patients with fibrinolytic conditions following consumption coagulopathy
Outcomes
Primary Outcomes
Not specified
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PeriOperative ISchemic Evaluation-3 (POISE-3) TrialThe occurrence of life-threatening, major, and critical organ bleeding, and, major arterial and venous thrombosis in patients undergoing noncardiac surgery. And for patients in the blood pressure management factorial, the occurrence of vascular death and major vascular events.MedDRA version: 20.0Level: LLTClassification code 10043611Term: Thrombosis arterialSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000539-29-BEHamilton Health Sciences Corporation10,000